Retrospective Study of Intensive Therapy Pathways (COLHEMI and Mini-COLHEMI Programs) in Children With Unilateral Cerebral Palsy: Care Trajectories, Bimanual Performance, and Goal Attainment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 主要终点
- Structured Description of Care Pathway Including Intensive Therapy
研究概览
简要总结
This retrospective single-center study aims to describe the care pathways of children with unilateral cerebral palsy (hemiplegia) who participated in intensive therapy programs (COLHEMI and/or Mini-COLHEMI) at the Centre des Massues since January 2010. The COLHEMI program (launched in 2010, for children aged 6-12) provides 70 hours of intensive motor learning-based therapy over 2 weeks, while the Mini-COLHEMI program (launched in 2020, for children from age 2) provides 30 hours over 2 weeks. The study will describe the immediate and medium-term impact of these programs on bimanual performance (Assisting Hand Assessment, AHA) and individualized goal attainment (Goal Attainment Scaling, GAS), analyze their impact on bimanual developmental trajectories using all available AHA scores, identify characteristics of good responders, and describe parent satisfaction. Approximately 75 patients will be included. Data are collected retrospectively from electronic and paper medical records by an occupational therapist.
详细描述
Background and Rationale Cerebral palsy (CP) is the most common cause of neurological disability in children, with a prevalence of approximately 2-2.5 per 1,000 live births in Europe. Hemiplegia, which accounts for approximately 30% of CP cases, predominantly affects the upper limb, impairing unimanual capacities, bimanual performance, and independence in activities of daily living.
The 2019 systematic review of evidence-based interventions for CP and subsequent international and French (HAS 2021) clinical practice guidelines strongly support intensive therapy approaches, including modified constraint-induced movement therapy (mCIMT), Hand and Arm Bimanual Intensive Training (HABIT), and HABIT-ILE. French HAS guidelines specifically recommend intensive rehabilitation programs of 60-90 hours incorporating motor learning principles targeting individualized functional goals.
Despite the strength of these recommendations, access to intensive therapy in France has historically been limited, leading many families to seek programs abroad. The Centre des Massues has proactively developed in-house intensive therapy programs integrated within its standard care pathway:
- COLHEMI (launched 2010): for children aged 6-12 years with unilateral CP; 70 hours over 2 weeks (10 therapy days), combining constraint-induced movement therapy, bimanual training, and goal-oriented therapy.
- Mini-COLHEMI (launched 2020): for children from age 2; 30 hours over 2 weeks (10 half-day sessions).
While these programs have been running for over a decade and generate systematic pre/post evaluations as part of routine care, their long-term impact on bimanual developmental trajectories and the factors associated with good response have not yet been formally studied.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minor patient (age < 18 years)
- •Unilateral upper limb involvement due to Cerebral Palsy (hemiplegia)
- •Having participated in at least one intensive therapy program (COLHEMI and/or Mini-COLHEMI) since program launch in January 2010
- •Participation before June 30, 2026
- •Followed at the CMCR des Massues
- •NON-INCLUSION CRITERIA
- •Parental opposition to medical data processing for research purposes
- •Incomplete medical record
排除标准
- 未提供
结局指标
主要结局
Structured Description of Care Pathway Including Intensive Therapy
时间窗: Full care trajectory from first intensive therapy program participation (from January 2010) to June 2026, collected retrospectively.
Structured description of each patient's care pathway, integrating: type (COLHEMI or Mini-COLHEMI) and number of intensive therapy sessions attended; associated medical treatments (botulinum toxin injections - nature, muscles targeted, and timing relative to each intensive therapy episode); associated surgical treatments (nature and timing relative to each intensive therapy episode); and type of regular rehabilitation follow-up (private practice, medico-social, health institution).
次要结局
- Immediate Impact on Bimanual Performance - Assisting Hand Assessment (AHA)(AHA score closest to the start of intensive therapy (within 3 months before) compared to AHA score closest to the end of intensive therapy (within 1 month after).)
- Immediate Goal Attainment - Goal Attainment Scaling (GAS)(Assessed immediately after each intensive therapy program.)
- Medium-Term Goal Attainment - Goal Attainment Scaling (GAS) at 3 Months(Assessed 3 months after each intensive therapy program.)
- Impact on Bimanual Developmental Trajectory - Longitudinal AHA Scores(All AHA scores available in the patient's medical record across the full care trajectory (from first available assessment to June 2026).)
- Characteristics of Good Responders to Intensive Therapy(Variables collected at baseline (pre-therapy) and analyzed against response status defined at immediate post-therapy and 3-month assessments.)
- Parent Satisfaction with Intensive Therapy Programs(2 weeks)